A randomized, active- and placebo-controlled study of the efficacy and safety of different doses of dutasteride versus placebo and finasteride in the treatment of male subjects with androgenetic alopecia

J Am Acad Dermatol. 2014 Mar;70(3):489-498.e3. doi: 10.1016/j.jaad.2013.10.049. Epub 2014 Jan 9.


Background: Dihydrotestosterone is the main androgen causative of androgenetic alopecia, a psychologically and physically harmful condition warranting medical treatment.

Objective: We sought to compare the efficacy and safety of dutasteride (type 1 and 2 5-alpha reductase inhibitor) with finasteride (type 2 5-alpha reductase inhibitor) and placebo in men with androgenetic alopecia.

Methods: Men aged 20 to 50 years with androgenetic alopecia were randomized to receive dutasteride (0.02, 0.1, or 0.5 mg/d), finasteride (1 mg/d), or placebo for 24 weeks. The primary end point was hair count (2.54-cm diameter) at week 24. Other assessments included hair count (1.13-cm diameter) and width, photographic assessments (investigators and panel), change in stage, and health outcomes.

Results: In total, 917 men were randomized. Hair count and width increased dose dependently with dutasteride. Dutasteride 0.5 mg significantly increased hair count and width in a 2.54-cm diameter and improved hair growth (frontal view; panel photographic assessment) at week 24 compared with finasteride (P = .003, P = .004, and P = .002, respectively) and placebo (all P < .001). The number and severity of adverse events were similar among treatment groups.

Limitations: The study was limited to 24 weeks.

Conclusions: Dutasteride increased hair growth and restoration in men with androgenetic alopecia and was relatively well tolerated.

Keywords: 5-alpha reductase; 5-alpha reductase inhibitors; androgenetic alopecia; dutasteride; finasteride; male pattern baldness; male pattern hair loss; treatment.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Alopecia / diagnosis
  • Alopecia / drug therapy*
  • Azasteroids / therapeutic use*
  • Confidence Intervals
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Dutasteride
  • Finasteride / therapeutic use*
  • Follow-Up Studies
  • Hair / drug effects*
  • Hair / growth & development
  • Humans
  • Male
  • Middle Aged
  • Patient Satisfaction
  • Reference Values
  • Time Factors
  • Treatment Outcome
  • Young Adult


  • Azasteroids
  • Finasteride
  • Dutasteride